Home / Recalls / Cardiovascular Systems, Inc. / Z-1095-2014

Z-1095-2014 Class III Terminated

Recalled by Cardiovascular Systems, Inc. — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
March 5, 2014
Initiation Date
January 27, 2014
Termination Date
May 5, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
318

Product Description

CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

Reason for Recall

Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline line that is used in our peripheral atherectomy device. This saline line was not part of the FDA approval for use in the coronary device. It therefore does not meet specification for this device. C

Distribution Pattern

USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.

Code Information

Lot: 85408 -85412, 85585 -85587, 87276, 87278, 87280, 87317, 87462, 87464, 87793, 87949 - 87952, 88520 - 88524, 88975 - 88979, 89498, 89501- 89504, 89952, 89954, 89956, 91876, 91877, 91891, 92124, 92156.

Other recalls by Cardiovascular Systems, Inc.

  • Z-0394-2022 Class I — WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Cat (November 22, 2021)
  • Z-2386-2021 Class II — STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, RE (July 21, 2021)
  • Z-2385-2021 Class II — DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, (July 21, 2021)
  • Z-3021-2018 Class II — CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Numbe (April 13, 2018)
  • Z-0506-2018 Class II — Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system (September 14, 2017)
  • Z-0505-2018 Class II — Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system (September 14, 2017)
  • Z-2122-2017 Class II — CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Numbe (April 14, 2017)
  • Z-1771-2017 Class II — ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. S (March 3, 2017)
  • Z-1877-2017 Class II — ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7 (February 9, 2017)
  • Z-1230-2017 Class II — DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbit (December 7, 2016)